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Aclaris Therapeutics, Inc. (NASDAQ: ACRS) is a leading clinical-stage biopharmaceutical company specializing in the development of innovative therapies for immuno-inflammatory diseases. Founded by dermatologists, Aclaris leverages its extensive expertise in dermatologic treatments to address significant unmet needs in both medical and aesthetic dermatology.
Aclaris operates primarily through two segments: therapeutics and contract research. The therapeutics segment focuses on identifying and developing novel therapies to treat immuno-inflammatory diseases. Key drug candidates in this segment include Zunsemetinib, an oral MK2 inhibitor, ATI-2138, an ITJ inhibitor, and ATI-1777, a topical JAK 1/3 inhibitor. The contract research segment generates revenue by offering laboratory services, which constitute a significant portion of the company’s revenue.
Recent milestones for Aclaris include the progression of ATI-2138 into Phase 2a proof-of-concept trials for T cell-mediated autoimmune diseases and the completion of enrollment for the ATI-1777 Phase 2b trial in atopic dermatitis. Preliminary data from these trials have shown promising results, paving the way for further clinical development. Aclaris has also announced partnerships with institutions like Washington University to explore additional therapeutic applications for its drug candidates.
Financially, Aclaris maintains a robust liquidity position. As of the end of 2023, the company holds approximately $181.9 million in cash, cash equivalents, and marketable securities, ensuring the capability to fund operations through 2025. Revenue generation is primarily driven by contract research services and strategic licensing agreements, such as the recent deal with Sun Pharmaceutical Industries, Inc., which grants exclusive rights under certain patents for the use of deuruxolitinib in treating alopecia areata and androgenetic alopecia.
Biosion has entered into an exclusive license agreement with Aclaris Therapeutics (NASDAQ: ACRS) for worldwide rights (excluding Greater China) to two immunology assets: BSI-045B and BSI-502. The deal includes an upfront payment of over $40 million, 19.9% of Aclaris common stock, and potential milestone payments exceeding $900M with tiered royalties.
BSI-045B, a clinical-stage anti-TSLP antibody, has shown promising results in a Phase 2a trial for atopic dermatitis with 22 patients. BSI-502 is a pre-clinical stage bispecific antibody targeting both TSLP and IL4R. The agreement grants Aclaris development and commercialization rights worldwide, except for Greater China.
Aclaris Therapeutics (NASDAQ: ACRS) has secured an exclusive global license agreement with Biosion for worldwide rights (excluding Greater China) to two key biologics: BSI-045B, a clinical-stage anti-TSLP monoclonal antibody, and BSI-502, a pre-clinical stage bispecific antibody targeting TSLP and IL4R. BSI-045B has shown promising results in a Phase 2a trial for atopic dermatitis with 22 patients. The company also announced the appointment of two new executives: Hugh Davis as President and COO, and Steven Knapp as EVP, Head of Regulatory & Quality. The agreement strengthens Aclaris' pipeline in immunology with both small and large molecule drugs.
Aclaris Therapeutics (NASDAQ: ACRS) has secured a $80 million private placement through the sale of 35,555,555 shares of common stock at $2.25 per share. The placement was led by Vivo Capital, with participation from both new and existing investors including Forge Life Science Partners, Rock Springs Capital, and RA Capital Management, among others. The transaction is expected to close around November 19, 2024. The proceeds will be used to fund research and development of the company's pipeline and general corporate purposes. The company has agreed to file a registration statement with the SEC for the resale of the shares.
Aclaris Therapeutics (NASDAQ: ACRS) reported Q3 2024 financial results with a net loss of $7.6 million, improved from $29.3 million in Q3 2023. Revenue decreased to $4.3 million from $9.3 million year-over-year. The company maintains a strong cash position of $173.4 million, expected to fund operations into 2028.
Key developments include the first patient dosed in the ATI-2138 Phase 2a trial for atopic dermatitis, with top-line data expected in H1 2025. R&D expenses decreased to $6.0 million from $23.9 million, while G&A expenses reduced to $5.7 million from $7.1 million in the prior year period.
Aclaris Therapeutics (NASDAQ: ACRS) has announced the dosing of the first patient in its Phase 2a clinical trial of ATI-2138, an investigational oral covalent inhibitor of ITK and JAK3, for treating moderate to severe atopic dermatitis. The open-label study aims to evaluate the safety, tolerability, pharmacokinetics, efficacy, and pharmacodynamics of ATI-2138 over a 12-week period.
The trial plans to enroll approximately 15 subjects in the United States, with primary endpoints focusing on safety-related parameters. Secondary endpoints include EASI response measures, vIGA response, and BSA response. Aclaris expects to release topline data from this trial in the first half of 2025.
Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company specializing in immuno-inflammatory diseases, has announced its participation in the 2024 Cantor Global Healthcare Conference. The company's management team will engage in a fireside chat on Tuesday, September 17, 2024, at 8:00 AM ET in New York.
Investors and interested parties can access a webcast of the fireside chat through the 'Events' page in the 'Investors' section of Aclaris' website, www.aclaristx.com. The webcast will remain archived on the company's website for a minimum of 30 days, allowing for later viewing.
Aclaris Therapeutics (NASDAQ: ACRS) reported its Q2 2024 financial results and provided a corporate update. Key highlights include:
1. Initiation of Phase 2a study activities for ATI-2138 in atopic dermatitis.
2. Strengthened balance sheet through sale of future OLUMIANT® royalties for up to $31.5 million.
3. Q2 2024 net loss of $11.0 million, compared to $29.6 million in Q2 2023.
4. Total revenue increased to $2.8 million in Q2 2024 from $1.9 million in Q2 2023.
5. R&D expenses decreased to $8.8 million from $25.3 million year-over-year.
6. Cash, cash equivalents, and marketable securities of $149.9 million as of June 30, 2024.
The company expects its current cash position, including the $26.5 million from the OLUMIANT® royalty sale, to fund operations into 2028.
Aclaris Therapeutics (NASDAQ: ACRS) has announced the sale of a portion of its future royalty payments and certain milestones for OLUMIANT® (baricitinib) to OMERS Life Sciences for up to $31.5 million. The deal includes a $26.5 million upfront payment and up to $5.0 million in potential milestone payments based on OLUMIANT sales in 2024. This non-dilutive transaction strengthens Aclaris' balance sheet, providing financial flexibility to pursue value-creating opportunities and invest in internal programs. OMERS acquires a portion of the royalty for worldwide net sales of OLUMIANT for alopecia areata from April 1, 2024, through the remainder of the royalty term, as well as 100% of the remaining anniversary milestone payments from Eli Lilly.
Aclaris Therapeutics (NASDAQ: ACRS) announced that Dr. Neal Walker, Interim President & CEO, will participate in a fireside chat at the Goldman Sachs 45th Annual Global Healthcare Conference. The event will take place on June 11, 2024, at 11:20 AM ET in Miami, Florida.
The chat will be webcasted and accessible via the company's website, where it will be archived for at least 30 days.
Aclaris Therapeutics reported its financial results for the first quarter of 2024 and provided a corporate update. The company is progressing ATI-2138 into a Phase 2a trial for atopic dermatitis. Aclaris also announced positive results for its various ITK inhibitor programs and highlighted financial data showing a decrease in net loss and revenue. The company anticipates lower cash expenditures in future quarters due to ongoing strategic reviews.
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